This study is a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) phase. The primary objective is to evaluate the safety and tolerability of KHN702 tablets in Chinese healthy volunteers(HVs).
This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be 7 cohorts in Part 1 and 3 cohorts in Part 2. The SAD study will enroll approximately 54 HVs across 7 dose cohorts. All participants in Part 1 will be administered with a single oral dose of KHN702 or its matching placebo under fasted condition. Approximately 30 HVs will be enrolled in the multiple ascending dose study. All participants in Part 2 will received KHN702 or placebo once daily for continuous 7 days (QD x 7d) in a double-blind manner. The safety and tolerability will be evaluated by monitoring and assessment of AEs, clinical laboratory tests (hematology, urinalysis, biochemistry, coagulation, etc.), physical examination findings, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Subject will receive a single KHN702 tablet or matching placebo orally in fasted state.
All participants will receive KHN702 tablet or matching placebo orally once a day for 7 days in fasted state.
The incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.
Time frame: From screening to Day 4 for Part 1, and Day 10 for Part 2.
Maximum observed plasma concentration (Cmax)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.
Time to reach maximum observed concentration (Tmax)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.
Area under the plasma concentration-curve across the dosing interval (AUC0-tau)
To characterise the steady state PK of KHN702 following oral multiple administration of KHN702.
Time frame: Day 1 to Day 10.
Terminal elimination half-life (t1/2)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.
Apparent total body clearance (CL/F)
Mengchang Yang Sichuan Provincial People's Hospital, Medical Doctor
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To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To characterise the single dose and steady state PK of KHN702 following oral administration of KHN702.
Time frame: Part I: Day 1 to Day 4. Part II: Day 1 to Day 10.